MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER F/MULTILOC SCR Ø4.5 W/SELFHOLD; SCREWDRIVER

Catalog Number	03.019.025
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthese reports an event in united arab emirates as follows: it was reported on (b)(6) 2023, that the newly consignment supplied multiloc screwdriver (03.019.025) is strongly attached to multiloc screws even without insertion of the retention pin.When the surgeon tries to pull out the screwdriver after inserting the screw, & after removing the retention pin, the screw pulls out from the bone with the driver, due to strong attachment between the screw & the tip of the screwdriver.Incident happened 3 times within the same surgery.Surgeon had to push the screw inside manually without using the screwdriver.It was the first case with this new consignment set.The surgery was for 30 minutes due to the reported event.The procedure was successfully completed.No fragments were generated.No patient outcome/consequences.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) scrdriver f/multiloc scr ø4.5 w/selfhold this is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Part number: 03.019.025 lot number: 539p607 manufacturing site: haegendorf release to warehouse date: 01.03.2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The photo was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned visual analysis of the photo revealed that the scrdriver f/multiloc scr ø4.5 w/selfhold had no signs of issue.Photo evidence shows the screw being assembled to the screwdriver, however, a functional test cannot be performed through photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the scrdriver f/multiloc scr ø4.5 w/selfhold.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SCRDRIVER F/MULTILOC SCR Ø4.5 W/SELFHOLD
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16555169
• Report Number: 8030965-2023-03250
• Device Sequence Number: 16852699
• Product Code: HXX
• UDI-Device Identifier: 07611819427259
• UDI-Public: (01)07611819427259
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 03.019.025
• Device Lot Number: 539P607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Patient Sex: Unknown